Balda Medical G M B H

FDA Filings

This page includes the latest FDA filings for Balda Medical G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3007963752
FEI Number3007963752
NameManish P Bhatt
Owner & OperatorBalda Medical GmbH
Contact AddressBergkirchener Strasse 228 -
Bad Oeynhausen DE-NW Nordrhein-Westfalen 32549 DE
Official Correspondent
  • Julia Dohm
  • 049-5734-513-2118
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4501 E Wall St 4501 E Wall St
Ontario, CA 91761 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device
Company
DeviceDate
Manish P Bhatt [Balda Medical GmbH]
N Cuvette BN ProSpec2015-05-22
Manish P Bhatt [Balda Medical GmbH]
Micro Cuvette Segment2015-05-22
Manish P Bhatt [Balda Medical GmbH]
Elecsys Assay Cup / Tip2015-05-22
Manish P Bhatt [Balda Medical GmbH]
Cuvette COBAS INTEGRA2015-05-22
Manish P Bhatt [Balda Medical GmbH]
COAGU CHEK Softclix2009-10-21
Manish P Bhatt [Balda Medical GmbH]
ACCU CHEK Softclix2009-10-21
Manish P Bhatt [Balda Medical GmbH]
ACCU CHEK Fastclix New2009-10-21

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020073030264Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyASSAY TIP/CUP54 PAL
2020073030067Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyASSAY TIP/CUP54 PAL
2020073030169Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyASSAY TIP/CUP54 PCS
2020073032520Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyASSAY TIP/CUP54 PAL
2020073031993Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyASSAY TIP/CUP54 PCS
2020073031169Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyASSAY TIP/CUP54 PAL
2020073032032Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyASSAY TIP/CUP54 PAL
2020072436421Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyASSAY TIP/CUP54 PAL
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